Vascular treatment devices and methods

ABSTRACT

An apparatus for performing a vascular treatment includes an intraluminal member that is controllingly moved during the vascular treatment. The intraluminal member of the vascular treatment device can be connected to a motor. The intraluminal member may be configured to retain endothelium during the vascular treatment procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/413,895, filed on Nov. 15, 2010, the disclosure of which is herebyincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This specification relates to the field of vascular treatment.

2. Description of the Related Art

Sclerotherapy can be used to treat blood vessels, blood vesselmalformations, and similar problems in other body systems, such as thelymphatic system, and has been used in various forms for over 150 years.In its more modern form, sclerotherapy has been used since the 1960's,in Europe, for treating various vein conditions such as; varicose veins,reticular veins, spider veins of the leg, and also some fine facialveins.

Sclerotherapy can be used to treat these conditions by instigatingvascular fibrosis and obliteration in response to irreversibleendothelial cellular destruction and exposure of the underlyingsubendothelial cell layer. This destruction is usually caused by theinjection of a sclerosant into the vein. However, if the injectedsclerosant is too weak, there may be no endothelial injury at all. Ifthe sclerosant is a little stronger, the varicose vessel is damaged, butrecanalization occurs and an incompetent pathway for retrograde bloodflow persists. Finally, if the injected sclerosant is too strong, thevaricose vessel endothelium is destroyed, but adjacent vessels that arenot targeted for treatment may also be damaged by the sclerosant.

The requirement for an ideal strength of the sclerosant is complicatedby the constant flow of blood through the vein that is being treated.This flow simultaneously dilutes, and thereby weakens, the sclerosant,while also transporting the sclerosant to other parts of the vascularsystem.

Thus, improved methods and devices for treating the vascular system aredesired.

SUMMARY OF THE INVENTION

In one embodiment, a vascular treatment apparatus comprises an elongatedintraluminal member shaped and dimensioned for passage through bloodvessels of a subject. The intraluminal member may include a proximal endand a distal end, wherein the distal end comprises a vein walldisruptor. The vein wall disrupter may be configured to scrape tissueoff of the inner wall of a blood vessel, and retain that tissue on thedisruptor during use.

In another embodiment, a vascular treatment apparatus comprises anelongated intraluminal member shaped and dimensioned for passage throughblood vessels of a subject, the intraluminal member including a proximalend and a distal end, wherein the distal end comprises a vein walldisruptor. The vein wall disrupter is configured to scrape tissue off ofthe inner wall of a blood vessel, and comprises structures thereinforming tissue storing regions. The structures may be cavities orthrough holes.

In some embodiments, these apparatus may comprise a source of sclerosantand a fluid channel between the source of sclerosant and the distal endof the elongated intraluminal member.

In another embodiment, a vascular treatment method comprises advancingan elongated intraluminal member from an access site and into the vein,damaging the inner vessel wall by performing a defined movement of theportion of the intraluminal member against the vein's endothelium. Thedamaging comprises removing endothelium tissue from the inner vesselwall and retaining endothelium tissue on the portion of the intraluminalmember while performing the defined movement.

In another embodiment, a method for permanently occluding a vein throughthe combined disruption of a vein vessel wall and application of asclerosant comprises advancing an elongated intraluminal member from anaccess site and into the vein, wherein the intraluminal member has aportion thereof configured to produce damage to the inner vessel wall ofthe vein under user control when performing a defined movement, damagingthe inner vessel wall by performing the defined movement of the portionof the intraluminal member against the vein's endothelium, injectingsclerosant into the vein and onto the damaged inner vessel wall,observing sclerosant exiting from the access site, and stoppinginjection of sclerosant in response to the observing.

In another embodiment, a method for permanently occluding a vein throughthe combined disruption of a vein vessel wall and application of asclerosant comprises orienting a subject with at least one extremitybelow their head, advancing an elongated intraluminal member from anaccess site and into a vein in the at least one extremity, wherein theintraluminal member has a portion thereof configured to produce damageto the inner vessel wall of the vein under user control when performinga defined movement, re-orienting the subject with the at least oneextremity approximately level with or slightly above their head,damaging the inner vessel wall by performing the defined movement of theportion of the intraluminal member against the vein's endothelium, andinjecting sclerosant into the vein and onto the damaged inner vesselwall. The extremity may be an arm or a leg.

The foregoing is a summary and thus contains, by necessity,simplifications, generalization, and omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is not intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteachings set forth herein. The summary is provided to introduce aselection of concepts in a simplified form that are further describedbelow in the Detailed Description. This summary is not intended toidentify key features or essential features of the claimed subjectmatter, nor is it intended to be used as an aid in determining the scopeof the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of an assembly of a vascular treatmentdevice.

FIG. 2A illustrates a longitudinal cross-sectional view of theembodiment illustrated in FIG. 1.

FIG. 2B illustrates the distal ends of the wire and sheath of FIG. 2A.

FIG. 2C illustrates the distal ends of the wire and sheath of FIG. 2Awith the distal end of the wire extending out from the end of thesheath.

FIG. 3A illustrates an embodiment of a distal end of a wire withmultiple sharp edges along an extended length.

FIG. 3B illustrates an embodiment of a distal wire end having aroughened surface and cavities formed therein.

FIG. 3C illustrates an embodiment of a distal wire tip having scrapingprojections and cavities formed as through holes.

FIG. 4 is flow chart of a first vascular treatment method.

FIG. 5 is a flow chart of a second vascular treatment method.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description and examples illustrate preferred embodimentsof the present invention in detail. Those of skill in the art willrecognize that there are numerous variations and modifications of thisinvention that are encompassed by its scope. Accordingly, thedescription of a preferred embodiment should not be deemed to limit thescope of the present invention. In this description, reference is madeto the drawings wherein like parts are designated with like numeralsthroughout.

FIG. 1 depicts a perspective view of one embodiment of exemplarycomponents of a vascular treatment device 10. These components can beconfigured to provide a range of functionalities to the vasculartreatment device 10. In some embodiments, a vascular treatment device 10can include features configured for stimulating vascular ablation, suchas, for example, an intraluminal member 22, a motorized drive system,including, for example, a motor, and/or control features and/or featuresconfigured for delivering liquid sclerosant. In some embodimentsdescribed further below, the intraluminal member comprises a wiresurrounded by a sheath, and the wire is rotatable within the sheath. Thespace between the sheath and the wire can be used as a passage to injectsclerosant as the wire rotates, and the distal end of the wire fauns avein wall disruptor.

In general, the vascular treatment device 10 of FIG. 1 is utilized byintroducing the intraluminal member into a vein of a subject, where thevein is to be ablated in a treatment for varicose veins for example. Thedistal end of the wire is extended from the distal end of the sheath,and the wire is rotated or otherwise moved to damage the endotheliumlining the inside surface of the vein. Sclerosant is also injected tothe region of damage through the sheath that forms an outer portion ofthe intraluminal member 22. The combination of endothelium damage plusthe sclerosant provides a highly effective vascular ablation procedurewith a minimum amount of injected sclerosant.

As depicted in FIG. 1, a vascular treatment device can include a handle12 and a cartridge 14. As explained below in greater detail, each of thehandle 12 and cartridge 14 can include features configured forstimulating vascular ablation and/or for delivering liquid sclerosant.In one embodiment, and as depicted in FIG. 1, the handle 12 and thecartridge 14 can comprise separate pieces. In another embodiment, ahandle 12 and a cartridge 14 can comprise an integrated component. Aperson of skill in the art will recognize that the present disclosure isnot limited to a specific configuration of the handle 12 and cartridge14 but broadly includes the range of functions and uses of a vasculartherapy device.

As further depicted in FIG. 1, the cartridge 14 can be, for example,sized and shaped to engagingly connect to the handle 12. In oneembodiment, and as shown in FIG. 1, this engaging connection can beachieved by fitting features of the handle 12 to features of thecartridge 14.

FIG. 2 depicts a side cross-section view of the vascular treatmentdevice 10 of FIG. 1. The vascular treatment device 10 depicted in FIG. 2comprises the same features discussed in relation to FIG. 1. Referringnow to both FIGS. 1 and 2, the cartridge 14 may include a sheath 30affixed to and extending from the cartridge 14, a wire 32, and acoupling 34. The wire 32 can be, for example, fixed to the coupling 34.A person of skill in the art will recognize that the wire 32 can beaffixed to the coupling 34 through a variety of techniques and methods.A person of skill in the art will further recognize that the wire 32 canbe affixed to a range of features of a vascular treatment device 10configured for driving the wire 32.

The wire 32 (and surrounding sheath) can comprise a variety of lengths.In some embodiments, a wire 32 can have a length matching the needs ofthe procedure. In some embodiments, a wire 32 can have a length, forexample, of up to 10 cm, up to 25 cm, up to 75 cm, or up to 150 cm.

The sheath 30 can be configured to define a lumen through which the wire32 runs, and can be configured to allow independent motion of the wirewithin the sheath. The sheath 30 can have a variety of inner and outerdiameters. In some embodiments, the sheath 30 can have an inner diameterranging from approximately 0.022 inches to 0.048 inches. In someembodiments, the sheath 30 can have an outer diameter ranging fromapproximately 0.025 inches to 0.051 inches. In some embodiments, theouter diameter of the sheath 30 can be in the range that is, forexample, consistent with the inner diameter of standard needles orvascular sheaths used for used for insertion of vascular catheters.

The sheath 30 may also include external markings at regular intervalswhich may guide the user to monitor the insertion or removal speed ofthe intraluminal member 22.

Some embodiments of a vascular treatment device 10 can be configured foruse with injectant. In some embodiments, the cartridge 14 can beconfigured for holding an injectant such as sclerosant in a syringe 36attached to the cartridge 14 at a coupler 28. Some embodiments of avascular treatment device 10 and/or a cartridge 14 configured for use inconnection with an injectant can be, for example, configured with valvesand connectors to facilitate such use. In some embodiments, a syringe 36can, for example, connect to a stopcock 38 on a cartridge 14. Thestopcock 38 shown in FIG. 2 can be configured to allow the removaland/or attachment of a syringe to the vascular treatment device 10during a procedure. In some embodiments, a stopcock 38 can be configuredto allow reloading of fluid and/or exchanging of containers to, forexample, change the injectant or the concentration of the injectant. Insome embodiments, the stopcock 38 can be configured to provideadditional functionality, such as, for example, mixing or aerating theinjectant. The output of the coupler 28 is in fluid communication withthe space between the sheath 30 and the wire 32 so that the injectantcan be pushed along this space to the distal end of the wire and sheathwhere the injectant (e.g. sclerosant) exits the sheath when installed inthe vein.

In use, the sheath 30 with the wire 32 inside may be introduced into thevein prior to coupling the cartridge 14 to the handle 12. At this time,the wire 32 may be fully enclosed by the sheath 30 as shown in FIG. 2B.After introduction, the cartridge 14 can be inserted into the handle 12,and the coupler 34 can engage a mating coupler 40 in the handle. Thecoupler 34 in the cartridge which is attached to the wire 32 may beslidable within the cartridge 14, so that when the coupler 34 in thecartridge is forced into engagement with the coupler 40, the distal endof the wire 32 is pushed out of the sheath 30, as shown in FIG. 2C. Thisexposes a portion of the wire 32 that is configured to damage theendothelium on the inner surface of the vein. The coupler 40 in thehandle 12 is attached to the shaft of a motor 42 in the handle that mayrotate the coupler 40, mated coupler 34, and attached wire 32 to scrapeand damage the inner wall of the vein. During this process, sclerosantmay be forced down the sheath, to exit the sheath in the region near thedistal end of the wire 32, as shown by arrows 46 in FIG. 2C.

Motor rotation may be controlled by a trigger 48 in the handle thatdepresses and releases a switch 50 to start and stop motor rotation. Thehandle 12 may further include a power source for the motor such asbattery 52.

The tips of the wire 32 can have a variety of configurations. Asillustrated in FIGS. 2B and 2C, the distal end of the wire 32 can have aspherical ball 46 at the tip. During rotation, this ball is the featurethat does the most damage to the endothelium on the inner vessel wall.Embodiments of vascular treatment devices such as illustrated in FIGS. 1through 2C are further described in U.S. Pat. Nos. 7,862,575 and7,967,834 which are incorporated herein by reference in theirentireties.

Although vascular ablation treatments using the above described vasculartreatment device have shown dramatic improvement over prior vascularablation methods, it has been found that the configurations of thedistal ends of the wire are sometimes not optimal. For example, it isadvantageous if the wire 32 removes and retains endothelium as itrotates within the vein. This retention of endothelium tissue on thewire 32 appears to increase friction and result in more complete andfaster damage to the inner wall of the vein. Wire tips that areconfigured to retain endothelium are described further below withrespect to FIGS. 3A through 3C.

As shown in FIG. 3A, one embodiment of a wire 32 can have a series ofsharp edged protrusions along an extended length of the distal end ofthe wire 32. This length of extension along which the protrusions areprovided may extend more than 1 cm or more than 5 cm from the tip of thewire 32. At the tip of the wire 32, a larger sharp edged protrusion 66can be provided. If desired, although not illustrated in FIG. 3A, alarger sharp edged protrusion can advantageously be provided at one ormore bends or corners 68 provided in the distal end of the wire 32.These sharp edges can cut and scrape the endothelium effectively,removing additional tissue. The spaces between the protrusions canretain endothelium tissue during the procedure.

In the embodiment of FIG. 3B, an extended length of the distal end ofthe wire 32 (e.g. more than 1 cm or more than 5 cm) is provided with aroughened surface. A roughened surface may be formed by subjecting aninitially smooth steel to abrasion, machining, blasting, chemicaletching such as acid etching (for example, nitric acid, hydrofluoricacid, hydrochloric acid, and/or sulfuric acid). A roughened outersurface may also be created by rolling onto an irregularly shaped guideto create surface irregularity. The wire 32 of FIG. 3B also comprisesrelatively large cavities 70 that can retain endothelium tissue scrapedoff the inner vessel wall by the roughened surface.

In the embodiment of FIG. 3C, an extended length of the distal end ofthe wire 32 (e.g. more than 1 cm or more than 5 cm) is provided withsharp edged protrusions 76, which may be formed as vanes or flangesextending from the sides of the wire 32. In this embodiment, cavitiesare provided as through holes 78 that can also retain endothelium tissueremoved by the protrusions 76. It will be appreciated that any of theprotrusions, cavities, roughened surface, etc. can be combined in avariety of manners on a single wire so that the distal end of the wire32 is configured to both scrape away and retain endothelium tissue fromthe inner vessel wall during the procedure. Advantageously, catching andretaining of the endothelium can, in some embodiments, improve clinicalresults because scraping of tissue against tissue can cause significantabrasion to the vessel wall by increasing friction.

As shown in FIGS. 3B and 3C, the very tip of the wire 32 can behemispherical. Alternatively, appointed tip can be used. A hemisphericaltip can also be roughened or textured. The distal end of the wire 32 canalso incorporate curved segments and straight segments. A straightsegment can be distal to a curved segment.

An ablation method can further include steps to protect againstover-injection of sclerosant, into the deep system. In some embodiments,an operator can observe the insertion point of the ablation device, andupon observing exiting sclerosant, an operator can stop injection ofadditional sclerosant. This is illustrated by the procedure of FIG. 4.In this method, at block 80, the physician first advances theintraluminal member into the vein of the subject. At block 82, thephysician damages the vein and, injects sclerosant to ablate the vein asdescribed above. At block 84, the physician stops injection ofsclerosant in response to observing sclerosant exiting the vein throughthe intrlauminal member access point. Injection can be stopped manually,for example, stopping pushing on the plunger of the syringe 36 of FIG. 1when sclerosant is observed exiting the access point. Advantageously,this protects against over-injection of sclerosant into the deep system,thus reducing complications of deep vein thrombosis.

In addition, methods of performing vessel ablation can include creatingand maintaining specific patient positioning. A patient can be, forexample, tilted to enable access to veins and then moved to a flatposition for performing the vessel ablation. This is illustrated by themethod shown in FIG. 5. In this method, at block 90, the subject isoriented with the extremity to be treated positioned below their head.This allows easy vein access for introducing the intraluminal memberinto the vein at block 92. After the intraluminal member is inserted, atblock 94 the subject is re-oriented with the extremity being treatedlevel with or above their head. The procedure is then continued at block96 where the inner vein wall is damaged and sclerosant is injected asdescribed above. Advantageously, a flat or slightly inclined patientposition allows blood and injectant to spill toward the untreated veinas the treated area of the vein gradually occludes. In one embodimentfor treatment of leg veins, the patient can be tilted with legs down tofacilitate vein access. The patient is then moved into a flat or onlyslightly head-down position. Advantageously, use of such patientpositioning increases success rates for the procedure by allowing bloodand sclerosant to spill toward the untreated vein which increases veinablation and decreases the risk of deep vein thrombosis. In prior veinablation procedures, the extremity being treated was maintained in aposition below the head. The combination of vessel damage with theinjection of sclerosant, however, allows the lifting of the extremityduring the procedure with improved outcomes.

The foregoing description details certain embodiments of the devices andmethods disclosed herein. It will be appreciated, however, that nomatter how detailed the foregoing appears in text, the devices andmethods can be practiced in many ways. As is also stated above, itshould be noted that the use of particular terminology when describingcertain features or aspects of the invention should not be taken toimply that the terminology is being re-defined herein to be restrictedto including any specific characteristics of the features or aspects ofthe technology with which that terminology is associated.

It will be appreciated by those skilled in the art that variousmodifications and changes may be made without departing from the scopeof the described technology. Such modifications and changes are intendedto fall within the scope of the embodiments. It will also be appreciatedby those of skill in the art that parts included in one embodiment areinterchangeable with other embodiments; one or more parts from adepicted embodiment can be included with other depicted embodiments inany combination. For example, any of the various components describedherein and/or depicted in the Figures may be combined, interchanged orexcluded from other embodiments.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to embodiments containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). It will be further understood by those within the art thatvirtually any disjunctive word and/or phrase presenting two or morealternative terms, whether in the description, claims, or drawings,should be understood to contemplate the possibilities of including oneof the terms, either of the terms, or both terms. For example, thephrase “A or B” will be understood to include the possibilities of “A”or “B” or “A and B.”

All references cited herein are incorporated herein by reference intheir entirety. To the extent publications and patents or patentapplications incorporated by reference contradict the disclosurecontained in the specification, the specification is intended tosupersede and/or take precedence over any such contradictory material.

The term “comprising” as used herein is synonymous with “including,”“containing,” or “characterized by,” and is inclusive or open-ended anddoes not exclude additional, unrecited elements or method steps.

1. A vascular treatment apparatus comprising: an elongated intraluminalmember shaped and dimensioned for passage through blood vessels of asubject, the intraluminal member including a proximal end and a distalend, wherein the distal end comprises a vein wall disruptor; wherein thevein wall disrupter is configured to scrape tissue off of the inner wallof a blood vessel, and retain that tissue on the disruptor during use.2. The apparatus of claim 1, wherein the distal end of the intraluminalmember terminates with a hemispheric free end.
 3. The apparatusaccording to claim 1, wherein the distal end of the intraluminal memberterminates with a pointed free end.
 4. The apparatus according to claims1, wherein the distal end of the intraluminal member terminates with atextured hemispheric free end.
 5. The apparatus according to claim 1,wherein the distal end of the intraluminal member has a roughenedsurface.
 6. The apparatus according to claim 1, wherein the distal endof the intraluminal member comprises a curved segment.
 7. The apparatusaccording to claim 1, wherein the distal end of the intraluminal membercomprises straight segment distal to the curved segment.
 8. Theapparatus according to claim 1, additionally comprising: a source ofsclerosant; and a fluid channel between the source of sclerosant and thedistal end of the elongated intraluminal member.
 9. A vascular treatmentapparatus comprising: an elongated intraluminal member shaped anddimensioned for passage through blood vessels of a subject, theintraluminal member including a proximal end and a distal end, whereinthe distal end comprises a vein wall disruptor; wherein the vein walldisrupter is configured to scrape tissue off of the inner wall of ablood vessel, and wherein the vein wall disruptor comprises structurestherein forming tissue storing regions.
 10. The apparatus of claim 9,wherein the structures comprise cavities.
 11. The apparatus of claim 10,wherein the structures comprise through holes.
 12. The apparatusaccording to claim 1, additionally comprising: a source of sclerosant;and a fluid channel between the source of sclerosant and the distal endof the elongated intraluminal member.
 13. A vascular treatment methodcomprising the following steps: advancing an elongated intraluminalmember from an access site and into the vein, wherein the intraluminalmember has a portion thereof configured to produce damage to the innervessel wall; damaging the inner vessel wall by performing a definedmovement of the portion of the intraluminal member against the vein'sendothelium, wherein the damaging comprises removing endothelium tissuefrom the inner vessel wall and retaining endothelium tissue on theportion of the intraluminal member while performing the definedmovement.
 14. The method of claim 13, comprising injecting sclerosantinto the vein and onto the damaged inner vessel wall.
 15. The method ofclaim 13, comprising retaining endothelium tissue in cavities on theportion of the intraluminal member.
 16. The method of claim 13,comprising retaining endothelium tissue in through holes on the portionof the intraluminal member.
 17. A method for permanently occluding avein through the combined disruption of a vein vessel wall andapplication of a sclerosant, comprising the following steps: advancingan elongated intraluminal member from an access site and into the vein,wherein the intraluminal member has a portion thereof configured toproduce damage to the inner vessel wall of the vein under user controlwhen performing a defined movement; damaging the inner vessel wall byperforming the defined movement of the portion of the intraluminalmember against the vein's endothelium; injecting sclerosant into thevein and onto the damaged inner vessel wall observing sclerosant exitingfrom the access site; and stopping injection of sclerosant in responseto the observing.
 18. The method according to claim 17, wherein aninjector is stopped to stop the injection of sclerosant.
 19. The methodaccording to claim 18, wherein the injector comprises a plunger in asyringe.
 20. A method for permanently occluding a vein through thecombined disruption of a vein vessel wall and application of asclerosant, comprising the following steps: orienting a subject with atleast one extremity below their head; advancing an elongatedintraluminal member from an access site and into a vein in the at leastone extremity, wherein the intraluminal member has a portion thereofconfigured to produce damage to the inner vessel wall of the vein underuser control when performing a defined movement; re-orienting thesubject with the at least one extremity approximately level with orslightly above their head; damaging the inner vessel wall by performingthe defined movement of the portion of the intraluminal member againstthe vein's endothelium; and injecting sclerosant into the vein and ontothe damaged inner vessel wall.
 21. A method according to claim 20,wherein the at least one extremity comprises at least one arm.
 22. Amethod according to claim 20 wherein the at least one extremitycomprises at least one leg.
 23. A method according to claim 41 whereinthe orienting and re-orienting the subject comprises tilting thesubject.